Should FDA Withdraw Its NDI Draft Guidance?

Following the release of FDA draft guidance on new dietary ingredients (NDI) in July, members of the dietary supplements industry have begun submitting their comments to FDA as part of the guidance’s open comment period. So far, several leading industry representatives have commented negatively on the guidance, with one law firm advising that the guidance be immediately withdrawn because its requirements “substantively” deviate from FDA’s original NDI rulemaking.

Well-known dietary supplements law firm Ullman, Shapiro & Ullman LLP narrowed in on the new draft guidance’s requirement that NDI notifications be filed any time a NDI ingredient is used in a new product formulation that was not included in the original NDI notification. By thus making the regulation product- rather than ingredient-specific, this requirement would effectively greatly burden dietary supplement companies, which would need to file NDI notifications for every new product formulation containing an NDI ingredient. For instance, even if a product containing a NDI ingredient is altered slightly—such as with the addition of one more ingredient—the draft guidance suggests that a new NDI notification would be required.

However, attorney Marc Ullman, who signed the firm’s letter to FDA, argued that in FDA’s Dietary Supplement Health and Education Act (DSHEA) final rule in 1997, the agency proposed the NDI requirement as applying to NDI ingredients only, and not finished products. Thus, Ullman states in his comments, the new draft guidance’s “position is in direct contravention to FDA’s existing NDI regulation…that clearly contemplates the submission of notifications for only New Dietary Ingredients rather than separate notifications for every dietary supplement product containing a combination of ingredients, one of which happens to be a New Dietary Ingredient.”

Moreover, Ullman argues, FDA should withdraw the guidance document immediately because the finished product- versus ingredient-specific issue drastically deviates from FDA’s original NDI regulation. “[This] amounts to a new rule insofar as it amends the preexisting rule of the NDI Regulation (21 CFR § 190.6),” Ullman wrote. “Because the Guidance Document essentially creates a ‘new dietary supplement’ notification process, it is fatally flawed, contrary to law, [and] should be immediately withdrawn and revised so that it is consistent with the existing NDI regulation.”

Moreover, Ullman wrote that such a drastic change would constitute an amendment to FDA’s original rule, and as such, the agency should take steps to revise its original rule and follow a more-formal procedure to do so under the Administrative Procedure Act (APA).

“Rather than comply with the requirements of the APA, use of Guidance Documents to essentially create new regulatory requirements allow agencies to avoid formal public comment,” he stated. “Judicial review of Draft Guidance documents is very limited and thus does not provide an adequate check on such guidelines as contemplated by the APA. Moreover, in those instances where judicial review is available, determining the amount of deference to give to the agency is very vague and unpredictable.”

Ullman continued to state that the draft guidance “while not having the force of and effect of law, provide[s] a back door vehicle for agencies to push industry in a specific manner, while severely limiting the ability of effected parties to question whether the Guidance is in compliance with existing law…”

To the press, Ullman added, “This is ‘rulemaking by guidance,’ which is frowned upon by Congress and the courts….To implement this change, they have to do it formally.”

Dietary supplement association the Council for Responsible Nutrition (CRN) also made public its comments submitted to FDA. In its letter, the association argues that FDA “grossly underestimated” the amount of time it states in the guidance that would be required for companies to prepare a NDI notification. (The agency estimates that notifications should take 20 hours to prepare, while CRN argues that estimates are closer to 100 to 350 hours per notification.)

Other industry concerns regarding the draft guidance have included disallowing synthetic ingredients, not requiring Generally Recognized as Safe ingredients to file NDI notifications, and possibly barring products with Investigational New Drug applications from filing NDI notifications. Whether industry submits comments to FDA on those points remains to be seen.

But expect many more comments to be submitted to the agency. In August, leading trade associations requested that FDA extend its 90-day draft guidance comment period, initially set to end October 3, 2011, an additional 45 days.